Category: <span>PHARMACEUTICAL NELIGENCE</span>

South Florida is home to some of the best health care facilities in the nation. Patients, both young and old, rely on the expertise of medical professionals and pharmaceutical experts to ensure that they get the best treatment without having to worry about suffering from a pharmaceutical error. One mistake by a nurse in Seattle led not only to the death of an 8-month-old girl, but also to the nurse’s suicide and pointed out the continued dangers of pharmaceutical negligence.

MSNBC reported on the story in late June, in which a nurse gave a baby 1.4 grams of calcium chloride instead of 140 milligrams. The article also pointed out a few startling statistics about pharmaceutical errors. Notably, 1 in 7 Medicare patients suffer serious harm because of medical errors and hospital infections each year, and 180,000 patients die. Furthermore, a Washington University researcher found that 92% of the doctors surveyed said that they’d experienced a near miss, a minor error or a serious error, while 57% confessed to a serious mistake. The nurse was eventually let go and the hospital noted that it followed a “Just Culture” model which “use[s] errors to identify and correct systemic problems, rather than focusing on penalizing individuals.”

So is Just Culture the best method for pharmaceutical error prevention? Studies have shown that other tactics like e-prescriptions give the same rate of error as handwritten prescriptions. Firing employees who commit errors may resolve short-term problems, but as the statistics show, long-term issues still persist and factors such as similar names of prescriptions will ultimately increase the likelihood of error. Other methods must be implemented to reduce the risk of error in hospitals and pharmacies.

The safety of our community is important to us. Medical professionals and pharmacies in South Florida must be held accountable to improve protocol and do everything they can to prevent pharmaceutical negligence. Contact our office and consult with a Florida pharmaceutical negligence attorney if you’ve been injured from a pharmaceutical error.

A recent warning from the FDA has highlighted a common mistake made by pharmacists: confusion of drug names.

Mixing up prescriptions due to the similarity of drug names is a common pharmaceutical error, and it’s something that Floridians should be aware of when heading to their local drug store. According to MedPage Today, the FDA issued a warning in June due to the 226 reports it received from confusing Risperidone (Risperdal), which is an antipsychotic, with Ropinirole (Requip), which treats Parkinson’s disease and Restless Legs Syndrome. These errors resulted in five individuals being hospitalized.

In its report, the FDA noted that some of the factors causing confusion were similar packaging, illegible handwriting of the prescription, and overlapping product characteristics, such as strength and dosage. It is important to understand that any pharmaceutical prescription error has the potential to cause serious illness and/ or death.

So the next time that you pick up your prescription, remember to carefully read the label carefully and inspect the actual medication to determine that the medication is actually used to treat your condition, especially with generics. In addition, don’t be afraid to ask your physician and your pharmacist about the uses of your medication. By taking a few precautions, you can reduce the risk of being a victim of pharmaceutical negligence.

These days, everything has gone electronic: banking, shopping, and even important documents are being transmitted through the internet. A recent study, however, of e-prescriptions (medical prescriptions sent electronically) shows that technology may not be the answer for preventing pharmaceutical errors in Florida.

Medical News Today reported on a study from the Journal of American Medical Information Association , in which Karen Nanji, M.D. evaluated over 3,800 e-prescriptions from pharmacy chains in Florida, Arizona and Massachusetts. The study found that the 11.7 percent of the prescriptions had mistakes, which researchers note is no better than the rate of error in handwritten prescriptions. The numbers show that a majority of the errors – 60.7 percent – were omissions of frequency, dosage and duration. Notably, there were about 190,000 physicians last year who were e-prescribing.

The results of this study are quite disappointing, considering that doctors have received Medicare bonuses for e-prescribing and that e-prescribing was supposed to save money and prevent pharmaceutical errors. Technology alone cannot ensure the health and safety of our loved ones. Other measures need to be taken to prevent these errors.

Pharmaceutical errors can lead to dangerous, even fatal, results. If you or someone you know has been injured due to a prescription error, consult with an attorney.

Earlier this month, Dr. Diane Harper stirred up discussion with her remarks about Gardasil, a vaccine manufactured by major pharmaceutical company Merck used to prevent the human papilloma virus (HPV) at the 4th International Public Conference on Vaccination. According to a report by The Bulletin, Dr. Harper, who was the lead researcher for Gardasil and Cervarix and is the director of the Gynecologic Cancer Prevention Research Group at the University of Missouri, stated that the drugs will do little to reduce the risk of cervical cancer. She went further to say that despite the fact that the drugs were recommended for young girls, there have been no clinical trials for girls under the age of 15.

What was surprising was that while Dr. Harper was speaking at the conference to promote the vaccine, many of her statements casted doubt on the utility of the drugs. According to Gardasil, there are four types of HPV. HPV 16 and 18 cause 70 percent of cervical cancer cases, while HPV 6 and 11 cause 90% of genital warts cases. While Gardasil has been promoted as an effective against HPV, Dr. Harper stated that 70 percent of all HPV cases treat themselves within a year, and 90% after two years. Only half of the remaining 10 percent develop into cervical cancer. Dr. Harper went further, stating that the incidence of cervical in the U.S. is very low, with four out of five women with cervical cancer living in developing countries. She also revealed that while Merck followed a group of girls under 16 years of age, it did not follow them long enough to draw conclusions as to the sufficiency of the presence of HPV antibodies.

The subject of vaccinations has been a hot topic lately, and in this case, one that South Florida women should be mindful of. The Bulletin article noted that since Gardasil’s inception in 2006, 15,037 girls reported adverse effects to the Vaccine Adverse Event Reporting System (VAERS), including lupus, paralysis, brain inflammation, and blood clots. The Center for Disease and Control Prevention (CDC) stated that there have been 44 reported deaths.

When considering taking a vaccine or any kind of medication, it is important that you always gather as much information as possible. Talk to your physician about your concerns and the possible side effects of taking certain vaccinations or medications and pay attention to reports and studies, both positive and negative, on these medications.

Pfizer, Inc. is under fire for a hormone-replacement drug produced by Wyerth, a company which it acquired earlier this year for $68 billion.

According to Daily Finance, a jury awarded a Philadelphia woman $3.75 million in compensatory damages and an undisclosed sum of punitive damages, finding a link between Pempro, a hormone drug taken for menopause treatment, and her breast cancer. The jury also found that Wyeth hid evidence of Pempro’s potential cancer risk. The woman took Pempro for five years before being diagnosed with breast cancer in 2002. Daily Finance stated that there are 9,000 more lawsuits pending across the U.S., with about 1,500 in Philadelphia alone.

Stories such as this raises concerns for South Floridians and other consumers around the country. Can we trust that pharmaceutical companies will do business responsibly and ethically with the care and safety of its customers in mind without negligently putting a defective and potentially harmful product on the market? Booster Shots, from the Los Angeles Times’ Health Section, reported on French researches who conducted a study on 133 clinical trials which were published throughout 2006 in major medical journals. Besides finding that 55 percent of the studies were funded by for-profit companies, about 11% of the studies did not report on the adverse effects of their trials.

The researchers also found that some of the reporting was distorted. For example, 36 of the studies did not distinguish between severe and mild side effects. Sixteen studies only included the most severe side effects, while 17 reported only common side effects and another 63 did not report on withdrawals of volunteers from the studies. So while the Consolidated Standards of Reporting Trials was amended back in 2001 to emphasize the importance of reporting all adverse effects and events, the French researchers concluded that from their study, more needs to be done to rectify these inadequesies. Booster Shots noted an editorial accompanying the study by Dr. John Ioannidis of the University of Ioannina School of Medicine in Greece, who saw the under-reporting by the companies as their intent on “silencing the evidence” of the potential harm.
Read more “Pfizer’s Prempro Brings Attention to Pharmaceutical Reporting Issue”

The Journal of Neurology has reported that common forms of Hormone Replacement Therapy (HRT) can shrink the brains of post-menopausal women. Researchers performed brain scans on 1,400 women aged 71 to 89 who participated in the Women’s Health Initiative, A major American Study.

The Study found that women who were being administered HRT had smaller brain volumes in two key areas than those given a placebo. Brain volume was lower in the frontal lobe and in the hippocampus. Both of these areas of the brain contribute to thinking and memory skills. Shrinkage of the hippocampus is a known risk factor for dementia.

This Study was ironically renowned for finding a link between long term HRT use and increased stroke risk. The question that must be examined is whether the Pharmaceutical Industry is going to continue to be allowed to obtain approval of their products without greater scrutiny.

The conventional wisdom is that the American F.D.A., which regulates the Pharmaceutical Industry, has the most stringent and arduous approval process on the planet. However, conventional wisdom appears to be nothing more than American Corporate propaganda as the overwhelming number of drugs that have been recalled or that have caused significant health problems has been staggering over the past ten years.

Too, often, we learn of the politicizing of the F.D.A., which is given its marching orders to treat the pharmaceutical industry with kid gloves. Former industry personnel end up working for the agency that is supposed to regulate the very same industry they just left, and are going to return to after this government stint.

We are supposed to have a government for the people, not for the corporations. Hopefully, the pendulum will be shifting back.